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This Client Case describes the usage of 'Clinical Trial Portal' for a Named Patient Program, more specifically for a 'Medical Need Program'.
In this Medical Need Program (MNP), participating Physicians use the web-Portal to register new Patients and request Medication.
The workflow and logistics is fully handled by the Portal. Each action results in a notification email being sent to the responsible person(s). Where needed, a Task Centre provides an overview of Tasks which are awaiting further action. Automated triggers signal further actions, like a reminder sent to Physicians to timely request Follow-up medication.
One of the main reasons for our client (Astellas Pharma) to decide for our web-based platform was the user-friendliness of our platform. Both for the participating Physicians and for the Sponsor.
In this specific example, some rather conflicting requirements had to be met in order to comply with legal regulations.
First of all, all standard regulations regarding securing Patient Privacy had to be met. Secondly, governement regulations required that Patient details had to be registered in order for the Sponsor to be able to prove, after being requested, that medication had been supplied to the proper patient.
An integrated 'Task Center' is used to assist users with their daily workflow. In this specific example each medication request had to be approved by the Medical Department. Therefore a Task was defined 'to approve medication requests'. This Task was assigned to a number of dedicated users.Rather then having to search for Site, Patient and Form, clicking the arrow in the Task Center forwards the user directly to the proper record.
Most of the actual workflow is regulated by using email notifications. The Portal allows to create email content. Flexible settings are available to define which users should receive an email, e.g. all users which are linked to a site.A full Audit Trail is available to track which emails have been sent (and to whom).
More information on this topic, including a price indication, can be found at medical-need-program.com.